ISO 11607 and the Medical Packaging Process
The international ISO 11607 standard exists the industry that supplies medical devices to patients in a healthcare environment.
It’s a set of rules and guidance on how to make sure that a medical product and its packaging will arrive in a safe and sterile condition. From the manufacturer’s door through to the hands of the end user.
If you manufacture medical devices that play a key role in supporting surgery, or i. If you make products that are inserted into a patient to administer treatments. Well, it, it stands to reason why you would need to follow a stringent set of packaging rules. Rules that minimize the risk of your products becoming contaminated. It’s literally a matter of life or deathlife-or-death importance.
Tried and tested ISO 11607 procedures set the standard. They’re recognized in the United States by the Food and Drug Administration (FDA) and across the European Union through the CE marking. You’ll also find it accepted in many other countries around the world.
Think of the ISO 11607 standard as a full guide to the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems. Or to put it simply: they’re important whenever medical devices are contained within sterile barrier systems and are sterilized before hitting the supply chain, en routeenroute to the customer.
ISO 11607 1 and ISO 11697 2
The ISO 11607 standard is conveniently split into the two following parts, covering the demands on packaging for terminally sterilized medical devices.
● ISO 11607 1: Part one establishes the requirements and methods for testing the sterile barrier systems and packaging systems. To make sure that they remain terminally sterilized from factory to end user.
● ISO 11607 2: Part two sets out the process requirements on a manufacturer when creating a sterile barrier system for their medical devices. What they should do to minimize any risk of contamination in the factory and through the supply chain. And how they should do it.
Key requirements of ISO 11607
ISO 11607 is a stringent standard to meet with a lot of requirements to meet. The most important takeaway message is this: any medical packaging must keep a device sterile until the moment of use. So, when it is removed from the package, the recipient can have absolute confidence that it doesn’t pose any contamination health risks. In fact, there’s even guidance on how the device should be removed safely from the package!
Next up – ISO 11607 clearly states that the packaging must be able to withstand the sterilization process itself, without becoming damaged.
In order for a product and package to be ‘terminally sterilized’ it often goes through a gas sterilization process. You typically find that ethylene oxide (EO) is used to sterilize medical devices. It’s a harsh gas that penetrates the packaging, so this must be taken into account. ISO 11607 demands that both the sterile barrier system – and protective packaging – must survive the sterilization process without defects. Which can take the form of degradation and discoloration, for example.
ISO 11607 presents the processes that a manufacturer must follow to protect medical devices from typical damage it could incur through the supply chain and whilst in storage. With a series of ‘real world’ testing procedures established to make sure that the package has the necessary shelf lifeshelf-life integrity. Everything from resistance to atmospheric pressure, compression and temperature fluctuation must be considered.
When it comes to the testing requirements of ISO11607, the medical devices manufacturer must follow a sampling method that is based on sound statistical foundations.
Put our ISO 11607 knowledge to the test
At Industrial Physics we can help you to understand and exceed every requirement laid out in ISO 11607. We make custom built inspection machines for all aspects of package validation testing – everything from burst and creep testing through to pressure decay and bubble leak testing. If you’d like to talk through any aspect of the ISO 11607 standard process and learn how your company can meet every expectation… just get in touch.